Shots:
- The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.
- Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).
- Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access, while supporting improved outcomes across diverse therapeutic areas.
Company: Arvinas and Pfizer
Product: Veppanu
Active Ingredient: Vepdegestrant
Disease: ESR1-Mutated Breast Cancer
Date: May 01, 2026
Shots:
- FDA approved Veppanu to treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercialization
- NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts (n=624: 270 were ESR1m positive) previously treated with CDK4/6 inhibitor + endocrine therapy
- Trial showed improved PFS (1EP) by 43% in ESR1-mutated pts (n=270), with mPFS of 5 vs 2.1mos. OS data was immature with 16% of deaths in this group at PFS analysis.
Company: BeOne Medicines
Product: Beqalzi
Active Ingredient: Sonrotoclax
Disease: R/R Mantle Cell Lymphoma
Date: May 13, 2026
Shots:
- The US FDA has granted accelerated approval to Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU
- Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52% ORR (16% CR), mTTR of 1.9mos., & mDoR of 15.8mos. at median response follow-up of 11.9mos.
- Continued approval remains contingent on confirmation of clinical benefit in the ongoing P-III (CELESTIAL-RRMCL) trial, while Beqalzi is also being evaluated in combination regimens, incl. with Brukinsa for CLL, with updated data expected at ASCO’26
Company: AstraZeneca
Product: Baxfendy
Active Ingredient: Baxdrostat
Disease: Hard-to-Control Hypertension
Date: May 15, 2026
Shots:
- The US FDA has approved Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment resistant hypertension
- Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension
- Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg) vs 8.7mmHg (PBO), with PBO-adjusted decrease of 9.8 (2mg) & 8.7 (1mg); effects were consistent across subgroups. Results were published in The NEJM
Company: Gilead
Product: Hepcludex
Active Ingredient: Bulevirtide-gmod
Disease: Chronic Hepatitis Delta Virus (HDV) Infection
Date: May 22, 2026
Shots:
- The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection
- Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up
- Trial showed significant improvements in HDV RNA reduction & ALT normalization vs delayed treatment at Wk. 48, while confirmatory trials remain ongoing to verify clinical benefit
Company: AbbVie
Product: Decnupaz
Active Ingredient: Pivekimab sunirine-pvzy
Disease: Blastic Plasmacytoid Dendritic Cell Neoplasm
Date: May 27, 2026
Shots:
- The US FDA has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN
- Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease
- Trial reported a 69.7% composite CR rate with 9.7mos. mDoR in newly diagnosed BPDCN pts, with 13 pts subsequently underwent stem cell transplant, while R/R pts achieved a 15.7% composite CR rate with 9.2mos. mDoR, with 6 pts able to receive post-study stem cell transplant
Company: Wockhardt
Product: Zaynich
Active Ingredient: Cefepime and Zidebactam
Disease: Complicated Urinary Tract Infection Including Pyelonephritis
Date: May 29, 2026
Shots:
- The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria
- Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated
- Zaynich is an injectable antibiotic combining the cephalosporin cefepime with zidebactam, a non-β-lactam antibacterial and β-lactamase inhibitor. Wockhardt has also submitted an MAA to the EMA
Company: Haisco Pharmaceutical
Product: Cypsedo
Active Ingredient: Cipepofol
Disease: Adult General Anesthesia Prior to Surgery
Date: May 29, 2026
Shots:
- The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery
- Cipepofol (Chinese trade name: Sishuning) is China’s first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation
- In Dec 2020, Cipepofol, approved by China’s NMPA, marked a significant advancement in clinical anesthesia and sedation care. After receiving FDA clearance for clinical trials in 2021, Cipepofol bypassed P-II studies and advanced directly to P-III trials in the US, completing all studies in 2024 with superior results versus the SoC
Company: Shionogi
Product: Xocova
Active Ingredient: Ensitrelvir
Disease: Post-Exposure Prophylaxis COVID-19 Prevention
Date: May 29, 2026
Shots:
- The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19
- Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on day 1 & 125 mg on days 2-5) or PBO (n=1,011) within 72 hours of symptom onset in the index case
- The trial demonstrated a 67% reduction in the risk of symptomatic COVID-19 through Day 10 vs PBO, met its 1EP in PEP. Xocova was generally well tolerated, with comparable adverse event rates between the treatment (15.1%) and PBO (15.5%), results were published in the NEJM on May 14, 2026
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